RightFit
Not yet recruitingNot applicable

GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer

A Multi-centre, Prospective Cohort Study to Explore the Relationship Between Changes in GDF-15 Levels and Treatment-related Adverse Events During T-DXd Treatment in Breast Cancer Patients.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for a link between a hormone called GDF-15 in the blood and side effects from the breast cancer drug T-DXd. It is for adults with advanced breast cancer who plan to start T-DXd. Researchers want to learn whether this hormone is linked to feeling sick, vomiting, and weight loss during treatment.

GRADE is trying to find out if there is a link between a hormone called GDF-15 and the side effects that people can experience when taking T-DXd. GDF-15 can be measured in the blood. GDF-15 levels in the blood will go up when the body is stressed under certain conditions, including breast cancer. There is a link between high GDF-15 levels and the nausea and vomiting experienced with "morning sickness" in pregnancy. It has also been shown that GDF-15 levels will go up with the use of other types of chemotherapy that are known to cause nausea and vomiting. Side effects such as feeling sick (nausea), vomiting and weight loss are common with T-DXd. Sometimes, these can be so severe that treatment needs to be stopped early. The investigators can't predict who will get bad side effects and who will not. If the investigators can find out if there is a link between GDF-15 and the side effects of T-DXd, they can use this information in future clinical trials.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • A tissue test shows breast cancer that has spread or is advanced and cannot be removed with surgery.
  • Your cancer is HER2-positive or HER2-low, meaning it has high or low levels of a protein called HER2.
  • You plan to start treatment with T-DXd.
  • You are expected to live at least 4 months.

Who can't join

  • The study doctor finds a current, treatable reason why you are eating less.
  • You receive food through a feeding tube or nutrients through a vein when you join the study.
  • You have ongoing loss of weight and muscle from something other than cancer or its treatment, which the study doctor thinks could make the results hard to understand.
  • You are following a diet that limits calories to lose weight.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participants aged ≥18 years. 2. Histologically confirmed diagnosis of metastatic/advanced unresectable HER2-positive or HER2-low breast cancer. 3. Planned to start treatment with T-DXd. 4. Life expectancy of at least 4 months. Exclusion Criteria: 1. Current active reversible causes of decreased food intake, as determined by the Investigator. 2. Receiving tube feedings or any kind of parenteral nutrition at the time of enrolment into the study. 3. Ongoing cachexia attributable to other reasons unrelated to cancer or cancer treatment as determined by the Investigator that may confound interpretation of weight loss due to T-DXd. 4. Current adherence to a calorie-restricted diet with the intention of weight loss.

Study sites (1)

MA